Duopress Tablet
Amlodipine + Olmesartan Medoxomil
5 mg + 20 mg
Incepta Pharmaceuticals Ltd.
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| Retail Price | 8.00 AED |
Available as:
Indications
Duopress Tablet is used for:
Hypertension
Adult Dose
Hypertension
5 mg/20 mg PO once daily initially; may increase the dose after 1-2 weeks; not to exceed 10 mg/40 mg
May be administered concomitantly with other antihypertensive agents
Child Dose
Renal Dose
Avoid use in severe renal impairment (CrCl< 20 mL/min).
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity to olmesartan, amlodipine or excipients
Coadministration with aliskiren in patients with diabetes mellitus
Precautions
Drugs that act on renin-angiotensin system can cause fetal injury and death when used in 2nd and 3rd trimesters of pregnancy. Olmesartan medoxomil should be discontinued as soon as possible once pregnancy is detected.
Hypotension in volume- or salt-depleted patients with treatment initiation may be anticipated. Start treatment under close supervision
Increased angina or myocardial infarction may occur upon dosage initiation or increase
Impaired renal function: changes in renal function may be anticipated in the susceptible individual
Sprue-like enteropathy has been reported. Consider discontinuation of Amlodipine + Olmesartan in cases where no other etiology is found
Caution in renal impairment; monitor serum creatinine and potassium levels periodically. Avoid use in severe renal & hepatic impairment. Caution in patients with aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Patients with primary aldosteronism may not respond to angiotensin receptor antagonist. Not recommended in lactation.
Pregnancy-Lactation
Pregnancy
Therapy can cause fetal harm in pregnant women; use of drugs that act on renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in first trimester have not distinguished drugs affecting renin-angiotensin system from other antihypertensive agents
When pregnancy is detected, discontinue therapy as soon as possible; consider alternative antihypertensive therapy during pregnancy
Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly.
Oligohydramnios in pregnant women who use drugs affecting renin-angiotensin system in second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
Perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate, based on week of gestation; patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Closely observe infants with histories of in utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to olmesartan
If oliguria or hypotension occur, utilize measures to maintain adequate blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function
Lactation
There is limited information regarding the presence of drug in human milk, effects on breastfed infant, or on milk production; amlodipine is present in human milk; olmesartan is present in rat milk
Because of potential for adverse effects on nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment
Interactions
Amlodipine: If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin.
Increased exposure of cyclosporin and tacrolimus.
Increased exposure of amlodipine when coadministered with CYP3A inhibitors.
Olmesartan medoxomil:
Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to an increased risk of renal impairment and loss of antihypertensive effect.
Dual inhibition of the renin-angiotensin system:
Increased risk of renal impairment, hypotension, and hyperkalemia.
Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose
Lithium: Increases in serum lithium concentrations and lithium toxicity
Contraindicated (3)
aliskiren
dantrolene
sparsentan
Serious - Use Alternative (30)
apalutamide
benazepril
captopril
ceftobiprole medocaril sodium
chloramphenicol
chloroquine
conivaptan
diltiazem
enalapril
enasidenib
enzalutamide
fexinidazole
fosinopril
idelalisib
ivosidenib
leniolisib
lisinopril
lithium
lofexidine
lonafarnib
moexipril
nifedipine
perindopril
potassium phosphates, IV
quinapril
ramipril
simvastatin
trandolapril
trofinetide
voxelotor
Adverse Effects
Side effects of Amlodipine + Olmesartan Medoxomil :
>10%
Peripheral edema (11%)
Frequency Not Defined
Palpitation,Nocturia,Urinary frequency,Orthostatic hypotension,Pruritus,Rash
Potentially Fatal: Acute renal failure.
Mechanism of Action
Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina.
Olmesartan is a selective and competitive angiotensin II Type 1 (AT1) receptor antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II. As a result, olmesartan relaxes blood vessels, hence lowering BP and increases blood supply and oxygen to the heart.
Note
Duopress 5 mg + 20 mg Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Amlodipine + Olmesartan Medoxomil. Duopress is availble in Bangladesh.
Farmaco BD drug index information on Duopress Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.